Thirty-day mortality after palliative radiotherapy in advanced cancer patients: Optimizing end-of-life care in Asia.

INTRODUCTION: Evidence-based guidelines recommend hypofractionated palliative radiotherapy (PRT); nonetheless, many patients receive prolonged course of PRT. To identify patients with limited benefits from PRT in end-of-life care, we evaluated the pattern of PRT at an Asian institution and factors associated with 30-day mortality after PRT (30dM). METHODS: We retrospectively reviewed 228 patients who died after PRT in Yonsei Wonju Severance Christian hospital between October 2014 and March 2022. The associations between clinical factors and survival were assessed using the Cox proportional hazards method. Survival was analysed using the existing models to evaluate their performance in our cohort. RESULTS: The median PRT duration was 13 (IQR, 7-15) days. Only 11.4% of the patients were treated with hypofractionated radiotherapy. One-third of the patients (32.9%) could not complete PRT and 39 (17.1%) died during PRT. The 30dM was 31.6%. The median time from PRT to death was 17 (IQR, 11-23) days for the patients who died within 30 days. The number of involved organs (≤2 vs. >2; P < 0.001), albumin level (<3.3 vs. ≥3.3; P = 0.016), admission during PRT (P < 0.001), admission 3 months before PRT (P = 0.036) and ICU care during PRT (P < 0.001) were prognostic factors. A comparison of survival based on the existing models yielded unsatisfactory results in our cohort. CONCLUSION: Almost one-third of the patients received PRT in the last 30 days of life. The use of hypofractionation for PRT was low in this Asian population. Further research is necessary to develop a predictive model of early mortality, allowing tailored end-of-life care for Asian patients.

Feasibility of artificial intelligence-driven interfractional monitoring of organ changes by mega-voltage computed tomography in intensity-modulated radiotherapy of prostate cancer.

PURPOSE: High-dose radiotherapy (RT) for localized prostate cancer requires careful consideration of target position changes and adjacent organs-at-risk (OARs), such as the rectum and bladder. Therefore, daily monitoring of target position and OAR changes is crucial in minimizing interfractional dosimetric uncertainties. For efficient monitoring of the internal condition of patients, we assessed the feasibility of an auto-segmentation of OARs on the daily acquired images, such as megavoltage computed tomography (MVCT), via a commercial artificial intelligence (AI)-based solution in this study. MATERIALS AND METHODS: We collected MVCT images weekly during the entire course of RT for 100 prostate cancer patients treated with the helical TomoTherapy system. Based on the manually contoured body outline, the bladder including prostate area, and rectal balloon regions for the 100 MVCT images, we trained the commercially available fully convolutional (FC)-DenseNet model and tested its auto-contouring performance. RESULTS: Based on the optimally determined hyperparameters, the FC-DenseNet model successfully auto-contoured all regions of interest showing high dice similarity coefficient (DSC) over 0.8 and a small mean surface distance (MSD) within 1.43 mm in reference to the manually contoured data. With this well-trained AI model, we have efficiently monitored the patient's internal condition through six MVCT scans, analyzing DSC, MSD, centroid, and volume differences. CONCLUSION: We have verified the feasibility of utilizing a commercial AI-based model for auto-segmentation with low-quality daily MVCT images. In the future, we will establish a fast and accurate auto-segmentation and internal organ monitoring system for efficiently determining the time for adaptive replanning.

Feasibility of internal-source tracking with C-arm CT/SPECT imaging with limited-angle projection data for online in vivo dose verification in brachytherapy: A Monte Carlo simulation study.

PURPOSE: The current protocol for use of the image-guided adaptive brachytherapy (IGABT) procedure entails transport of a patient between the treatment room and the 3-D tomographic imaging room after implantation of the applicators in the body, which movement can cause position displacement of the applicator. Moreover, it is not possible to track 3-D radioactive source movement inside the body, even though there can be significant inter- and intra-fractional patient-setup changes. In this paper, therefore, we propose an online single-photon emission computed tomography (SPECT) imaging technique with a combined C-arm fluoroscopy X-ray system and attachable parallel-hole collimator for internal radioactive source tracking of every source position in the applicator. METHODS AND MATERIALS: In the present study, using Geant4 Monte Carlo (MC) simulation, the feasibility of high-energy gamma detection with a flat-panel detector for X-ray imaging was assessed. Further, a parallel-hole collimator geometry was designed based on an evaluation of projection image quality for a 192Ir point source, and 3-D limited-angle SPECT-image-based source-tracking performances were evaluated for various source intensities and positions. RESULTS: The detector module attached to the collimator could discriminate the 192Ir point source with about 3.4% detection efficiency when including the total counts in the entire deposited energy region. As the result of collimator optimization, hole size, thickness, and length were determined to be 0.5, 0.2, and 45 mm, respectively. Accordingly, the source intensities and positions also were successfully tracked with the 3-D SPECT imaging system when the C-arm was rotated within 110° in 2 seconds. CONCLUSIONS: We expect that this system can be effectively implemented for online IGABT and in vivo patient dose verification.

Dose-escalated radiotherapy for clinically localized and locally advanced prostate cancer.

BACKGROUND: Treatments for clinically localized prostate cancer include radical prostatectomy, external beam radiation therapy, brachytherapy, active surveillance, hormonal therapy, and watchful waiting. For external beam radiation therapy, oncological outcomes may be expected to improve as the dose of radiotherapy (RT) increases. However, radiation-mediated side effects on surrounding critical organs may also increase. OBJECTIVES: To assess the effects of dose-escalated RT in comparison with conventional dose RT for curative treatment of clinically localized and locally advanced prostate cancer. SEARCH METHODS: We performed a comprehensive search using multiple databases including trial registries and other sources of grey literature, up until 20 July 2022. We applied no restrictions on publication language or status. SELECTION CRITERIA: We included parallel-arm randomized controlled trials (RCTs) of definitive RT in men with clinically localized and locally advanced prostate adenocarcinoma. RT was dose-escalated RT (equivalent dose in 2 Gy [EQD2] ≥ 74 Gy, lesser than 2.5 Gy per fraction) versus conventional RT (EQD2 < 74 Gy, 1.8 Gy or 2.0 Gy per fraction). Two review authors independently classified studies for inclusion or exclusion. DATA COLLECTION AND ANALYSIS: Two review authors independently abstracted data from the included studies. We performed statistical analyses by using a random-effects model and interpreted them according to the Cochrane Handbook for Systematic Reviews of Interventions. We used GRADE guidance to rate the certainty of the evidence of RCTs. MAIN RESULTS: We included nine studies with 5437 men in an analysis comparing dose-escalated RT versus conventional dose RT for the treatment of prostate cancer. The mean participant age ranged from 67 to 71 years. Almost all men had localized prostate cancer (cT1-3N0M0). Primary outcomes Dose-escalated RT probably results in little to no difference in time to death from prostate cancer (hazard ratio [HR] 0.83, 95% CI 0.66 to 1.04; I2 = 0%; 8 studies; 5231 participants; moderate-certainty evidence). Assuming a risk of death from prostate cancer of 4 per 1000 at 10 years in the conventional dose RT group, this corresponds to 1 fewer men per 1000 (1 fewer to 0 more) dying of prostate cancer in the dose-escalated RT group. Dose-escalated RT probably results in little to no difference in severe RT toxicity of grade 3 or higher late gastrointestinal (GI) toxicity (RR 1.72, 95% CI 1.32 to 2.25; I2 = 0%; 8 studies; 4992 participants; moderate-certainty evidence); 23 more men per 1000 (10 more to 40 more) in the dose-escalated RT group assuming severe late GI toxicity as 32 per 1000 in the conventional dose RT group. Dose-escalated RT probably results in little to no difference in severe late genitourinary (GU) toxicity (RR 1.25, 95% CI 0.95 to 1.63; I2 = 0%; 8 studies; 4962 participants; moderate-certainty evidence); 9 more men per 1000 (2 fewer to 23 more) in the dose-escalated RT group assuming severe late GU toxicity as 37 per 1000 in the conventional dose RT group. Secondary outcomes Dose-escalated RT probably results in little to no difference in time to death from any cause (HR 0.98, 95% CI 0.89 to 1.09; I2 = 0%; 9 studies; 5437 participants; moderate-certainty evidence). Assuming a risk of death from any cause of 101 per 1000 at 10 years in the conventional dose RT group, this corresponds to 2 fewer men per 1000 (11 fewer to 9 more) in the dose-escalated RT group dying of any cause. Dose-escalated RT probably results in little to no difference in time to distant metastasis (HR 0.83, 95% CI 0.57 to 1.22; I2 = 45%; 7 studies; 3499 participants; moderate-certainty evidence). Assuming a risk of distant metastasis of 29 per 1000 in the conventional dose RT group at 10 years, this corresponds to 5 fewer men per 1000 (12 fewer to 6 more) in the dose-escalated RT group developing distant metastases. Dose-escalated RT may increase overall late GI toxicity (RR 1.27, 95% CI 1.04 to 1.55; I2 = 85%; 7 studies; 4328 participants; low-certainty evidence); 92 more men per 1000 (14 more to 188 more) in the dose-escalated RT group assuming overall late GI toxicity as 342 per 1000 in the conventional dose RT group. However, dose-escalated RT may result in little to no difference in overall late GU toxicity (RR 1.12, 95% CI 0.97 to 1.29; I2 = 51%; 7 studies; 4298 participants; low-certainty evidence); 34 more men per 1000 (9 fewer to 82 more) in the dose-escalated RT group assuming overall late GU toxicity as 283 per 1000 in the conventional dose RT group. Based on long-term follow-up (up to 36 months), dose-escalated RT may result or probably results in little to no difference in the quality of life using 36-Item Short Form Survey; physical health (MD -3.9, 95% CI -12.78 to 4.98; 1 study; 300 participants; moderate-certainty evidence) and mental health (MD -3.6, 95% CI -83.85 to 76.65; 1 study; 300 participants; low-certainty evidence), respectively. AUTHORS' CONCLUSIONS: Compared to conventional dose RT, dose-escalated RT probably results in little to no difference in time to death from prostate cancer, time to death from any cause, time to distant metastasis, and RT toxicities (except overall late GI toxicity). While dose-escalated RT may increase overall late GI toxicity, it may result, or probably results, in little to no difference in physical and mental quality of life, respectively.

Long-Term Feasibility of 13.56 MHz Modulated Electro-Hyperthermia-Based Preoperative Thermoradiochemotherapy in Locally Advanced Rectal Cancer.

We evaluated the effect of 13.56 MHz modulated electro-hyperthermia (mEHT) boost in neoadjuvant treatment for cT3-4- or cN-positive rectal cancer. Sixty patients who completed the mEHT feasibility trial (ClinicalTrials.gov Identifier: NCT02546596) were analyzed. Whole pelvis radiotherapy of 40 Gy, mEHT boost twice a week during radiotherapy, and surgical resection 6-8 weeks following radiotherapy were performed. The median age was 59. The median follow-up period was 58 (6-85) months. Total/near total tumor regression was observed in 20 patients (33.3%), including nine cases of complete response. T- and N-downstaging was identified in 40 (66.6%) and 53 (88.3%) patients, respectively. The 5-year overall and disease-free survival were 94.0% and 77.1%, respectively. mEHT energy of ≥3800 kJ potentially increased the overall survival (p = 0.039). The ypN-stage and perineural invasion were possible significant factors in disease-free (p = 0.003 and p = 0.005, respectively) and distant metastasis-free (p = 0.011 and p = 0.034, respectively) survival. Tumor regression, resection margin status, and other molecular genetic factors showed no correlation with survival. Although a limited analysis of a small number of patients, mEHT was feasible considering long-term survival. A relatively low dose irradiation (40 Gy) plus mEHT setting could ensure comparable clinical outcomes with possible mEHT-related prognostic features.

Development of a direction-sensitive gamma-ray monitoring system using a gamma camera with a dual-sided collimator: A Monte Carlo study.

Nuclear explosions, sabotage, and dirty bomb materials are considered a security threat. This paper discusses the development of a gamma-ray monitoring system that enables the screening of nuclear materials moving simultaneously on both sides of the system at ports. This direction-sensitive gamma-ray monitoring (DSGM) system consists of a monolithic plastic scintillator surrounded by 28 photomultiplier tubes and dual-sided parallel-hole lead collimators. With Monte Carlo simulation, the monitoring performance of the DSGM system was assessed for static and moving sources. A multilayer perceptron model was employed to estimate the energy-deposited position of the gamma-rays emitted by nuclear materials in the scintillator.

Beneficial effects of modulated electro-hyperthermia during neoadjuvant treatment for locally advanced rectal cancer.

PURPOSE: Modulated electro-hyperthermia (mEHT) may enhance the tumor response, although the effectiveness of combined neoadjuvant therapy remains unclear. Therefore, we investigated the role of mEHT with neoadjuvant therapy for locally advanced rectal cancer. MATERIALS AND METHODS: Clinical data were analyzed for 120 patients who received neoadjuvant treatment for locally advanced rectal cancer (T3/4 or N+, M0) from May 2012 to December 2017. Capecitabine or 5-fluorouracil was administered along with radiotherapy. Patients were categorized into mEHT group (62 patients) and non-mEHT group (58 patients) depending on whether mEHT was added. Surgery was performed 6-8 weeks after the end of radiotherapy. RESULTS: The median age was 59 years (range, 33-83). The median radiation dose was significantly less for mEHT group (40 Gy) than for non-mEHT group (50.4 Gy). In mEHT group, 80.7% showed down-staging compared with 67.2% in non-mEHT group. For large tumors of more than 65 cm³ (mean), improved tumor regression was observed in 31.6% of mEHT group compared with 0% of non-mEHT group (p = .024). The gastrointestinal toxicity rate of mEHT group was 64.5%, which was found to be statistically significantly less than 87.9% of non-mEHT group (p = .010). The 2-year disease-free survival was 96% for mEHT group and 79% for non-mEHT group (p = .054). CONCLUSION: The overall mEHT group had a comparable response and survival using less radiation dosing compared with standard care; the subgroup with large tumors showed improved efficacy for tumor regression after mEHT.

Assessment of inter- and intra-fractional volume of bladder and body contour by mega-voltage computed tomography in helical tomotherapy for pelvic malignancy.

PURPOSE: We describe the daily bladder volume change observed by mega-voltage computed tomography (MVCT) during pelvic radiotherapy with potential predictors of increased bladder volume variations. MATERIALS AND METHODS: For 41 patients who received pelvic area irradiation, the volumes of bladder and pelvic body contour were measured twice a day with pre- and post-irradiation MVCT from the 1st to the 10th fraction. The median prescription dose was 20 Gy (range, 18 to 30 Gy) up to a 10th fraction. The upper and lower margin of MVCT scanning was consistent during the daily treatments. The median age was 69 years (range, 33 to 86 years) and 10 patients (24.4%) were treated postoperatively. RESULTS: Overall bladder volume on planning computed tomography was 139.7 ± 92.8 mL. Generally, post-irradiation bladder volume (POSTBV) was larger than pre-irradiation bladder volume (PREBV) (p < 0.001). The mean PREBV and POSTBV was reduced after 10 fraction treatments by 21.3% (p = 0.028) and 25.4% (p = 0.007), respectively. The MVCT-scanned body contour volumes had a tendency to decrease as the treatment sessions progressed (p = 0.043 at the 8th fraction and p = 0.044 at the 10th fraction). There was a statistically significant correlation between bladder filling time and PREBV (p = 0.001). CONCLUSION: Daily MVCT-based bladder volume assessment was feasible both intra- and inter-fractionally.

Pancreatic radiation effect in apoptosis-related rectal radiation toxicity.

Pancreatic radiation effect (PRE) can be a component of gastrointestinal tract (GIT) radiotoxicity. This inter-organ correlation between the GIT and the pancreas was assessed through a rat model. Separate local irradiation to the abdomen and the pelvis was applied concurrently for 8-week-old male Sprague Dawley rats. Abdominal irradiation was categorized into pancreatic shield (PS) and non-pancreatic shield (NPS) irradiation. After 5 Gy and 15 Gy irradiation, the rectal mucosa was analyzed at the first week (early phase, Ep) and the 14th week (late phase, Lp). A slow gain in body weight was observed initially, particularly in the NPS group receiving a 15 Gy dose (P < 0.001). The large number of apoptotic bodies after 15 Gy at Ep decreased at Lp. At Ep for the 5-Gy group, the NPS group revealed more fibrotic change than the PS group (P = 0.002). Cleaved caspase-3 (CCP3) expression was greater at Lp, and the Ep-Lp increase was prominent in the NPS-15-Gy group (P = 0.010). At Lp, for 15 Gy irradiation, CCP3 was expressed more in the NPS group than in the PS group (P = 0.032). Despite no direct toxicity difference between the PS and NPS groups, small changes in parameters such as fibrosis or CCP3 expression suggest that pancreatic shielding does have an effect on the radiation response in the rectal mucosa, which suggests a need for a multi-organ effect-based approach in GIT radiotoxicity assessment.

Influence of different boost techniques on radiation dose to the left anterior descending coronary artery.

PURPOSE: The purpose of this study is to compare the dosimetry of electron beam (EB) plans and three-dimensional helical tomotherapy (3DHT) plans for the patients with left-sided breast cancer, who underwent breast conserving surgery. MATERIALS AND METHODS: We selected total of 15 patients based on the location of tumor, as following subsite: subareolar, upper outer, upper inner, lower lateral, and lower medial quadrants. The clinical target volume (CTV) was defined as the area of architectural distortion surrounded by surgical clip plus 1 cm margin. The conformity index (CI), homogeneity index (HI), quality of coverage (QC) and dose-volume parameters for the CTV, and organ at risk (OAR) were calculated. The following treatment techniques were assessed: single conformal EB plans; 3DHT plans with directional block of left anterior descending artery (LAD); and 3DHT plans with complete block of LAD. RESULTS: 3DHT plans, regardless of type of LAD block, showed significantly better CI, HI, and QC for the CTVs, compared with the EB plans. However, 3DHT plans showed increase in the V1Gy at skin, left lung, and left breast. In terms of LAD, 3DHT plans with complete block of LAD showed extremely low dose, while dose increase in other OARs were observed, when compared with other plans. EB plans showed the worst conformity at upper outer quadrants of tumor bed site. CONCLUSION: 3DHT plans offer more favorable dose distributions to LAD, as well as improved target coverage in comparison with EB plans.

Toxicity of tomotherapy-based simultaneous integrated boost in whole-pelvis radiation for prostate cancer.

PURPOSE: The validity of tomotherapy-based simultaneous integrated boost (TOMOSIB) was assessed in terms of acute intestinal/urinary toxicity by comparing with 3-dimensional conformal radiotherapy (3DCRT) in cases of whole-pelvis radiation therapy (WPRT) for prostate cancer. MATERIALS AND METHODS: Thirty-eight consecutive patients who underwent curative WPRT were retrospectively reviewed. Twenty six (68.4%) received 3DCRT and the others (31.6%) were treated with TOMOSIB. A local boost to the prostate circumferential area was added to WPRT sequentially for 3DCRT and concomitantly for TOMOSIB. The total median prostate or prostatic bed dose was 64.8 Gy including median 45.0 Gy of WPRT. Acute toxicities were assessed according to RTOG criteria. RESULTS: Overall intestinal toxicity was lower in TOMOSIB group than 3DCRT group (p=0.008). When it was divided into rectum and non-rectum intestine (NRI), TOMOSIB showed borderline superiority only in NRI toxicity (p=0.047). For the urinary toxicity, there was no significant difference between two groups (p=0.796). On dosimetric analysis for the rectum and bladder, dose delivered to 80% (p<0.001) and volume receiving 25-40 Gy (p<0.001) were remarkably higher in 3DCRT. For the NRI, only maximum dose showed significant results between two groups (p<0.001). CONCLUSION: Intestinal toxicity should be verified with more detailed anatomic categorization such as rectum and NRI. TOMOSIB could not reduce urinary toxicity because of inevitably high dose exposure to the prostatic urethra. Current dosimetry system did not properly reflect intestinal/urinary toxicity, and suitable dosimetric guidelines are needed in TOMOSIB.

Neutrophil-lymphocyte ratio predicts pathologic tumor response and survival after preoperative chemoradiation for rectal cancer.

BACKGROUND: Neutrophil-lymphocyte ratio (NLR) reflects the balance between pro- and anti-tumor immune activities. We evaluated whether NLR is associated with pathologic tumor response and prognosis in rectal cancer patients that underwent preoperative chemoradiaton therapy (CRT) with surgery. METHODS: One hundred two patients with rectal cancer that were treated by preoperative CRT followed by surgery were enrolled. A total of 50.4 GY of radiation and 5-FU-based chemotherapy were delivered. An NLR ≥ 3 was considered to be elevated. Pathologic tumor response based on ypTNM stage was categorized into two groups, good response (n = 35, pathologic complete response and ypTNM I) and poor response groups (n = 67, ypTNM II, III, and IV). RESULTS: Twenty-five patients (24.5%) had elevated NLR. Multivariate analysis showed that an elevated CEA level (p = 0.001), larger tumor (p = 0.03), and elevated NLR (p = 0.04) were significant predictors for a poor response. Poor pathological tumor response and elevated NLR were risk factors for cancer-specific and recurrence-free survivals. CONCLUSION: An elevated NLR before CRT can be used as predictors for poor tumor response and unfavorable prognostic factors. Dominant pro-tumor activities of neutrophils or reduced anti-tumor immune response by lymphocytes, as determined by NLR, may have a impact on poor tumor response and unfavorable prognosis.

Second primary brain tumors following cranial irradiation for pediatric solid brain tumors.

PURPOSE: We describe our institution's experience with seven patients who developed second brain tumors following cranial irradiation. METHODS: The median age at first irradiation was 8 years (range, 3-20 years). Initial diagnoses were two cases of germinoma, one non-germinomatous germ cell tumor (NGGCT), three cases of medulloblastoma, and one pineal gland tumor (pathology undetermined). All patients received craniospinal irradiation followed by local boost and the median dose to the initial tumor area was 54.0 Gy (range, 49.8-60.6 Gy). Four patients (two medulloblastomas, one germinoma, and one NGGCT) received chemotherapy. RESULTS: Second brain tumors were diagnosed a median of 114 months (range, 64-203) after initial radiation. Pathologic diagnoses were one glioblastoma, two cases of anaplastic astrocytoma, one medulloblastoma, one low-grade glioma, one high-grade glial tumor, and one atypical meningioma. Five patients underwent surgical resection with subsequent radiotherapy. One anaplastic astrocytoma patient received chemotherapy only following stereotactic biopsy. The meningioma patient was alive 32 months after total resection and radiosurgery for subsequent recurrences. Six patients died within 18 months and most deaths were due to disease progression. CONCLUSIONS: Most patients diagnosed with second brain tumors had received high-dose, large-volume radiotherapy with chemotherapy at a young age. Further studies are required to determine the relationship between radiotherapy/chemotherapy and the development of secondary brain tumors.

Is there a clinical benefit to adaptive planning during tomotherapy in patients with head and neck cancer at risk for xerostomia?

OBJECTIVES: To evaluate the necessity of adaptive planning in helical tomotherapy (TOMO) for head and neck cancer in terms of dosimetric influence on the parotid gland. METHODS: Thirty-one patients underwent curative TOMO for head and neck cancer from April 2006 to April 2007. For each patient, neck diameter was monitored together with body weight at first cervical spine level through mega-voltage computed tomography during the TOMO course. Ten of 31 patients, with significant weight loss (>5%) and/or neck diameter decrease (>10%), were selected for dosimetric analysis, and parotid dose was recalculated at the fourth and last week of TOMO. Xerostomia was estimated by Radiation Therapy Oncology Group criteria. RESULTS: The median dose was 69.96 Gy (range, 54 to 69.96 Gy) and there was no grade 3 or greater complication. Ten patients with significant neck diameter decrease and/or weight loss showed frequent grade 2 acute xerostomia (P=0.02). The volume percentage of daily fractional dose over 0.75 Gy for the parotid gland (V0.75 Gy) increased by 23.6% at the end of TOMO. CONCLUSIONS: For patients with significant anatomic contour change; neck diameter decrease (>10%) or weight loss (>5%), adaptive planning using mega-voltage computed tomography can identify dosimetric changes and reduce deleterious side effects such as xerostomia.

Effect of Oral Supplementation with Branched-chain Amino Acid (BCAA) during Radiotherapy in Patients with Hepatocellular Carcinoma: A Double-Blind Randomized Study.

PURPOSE: The present study evaluated whether oral supplementation with a branched-chain amino acid (BCAA) improves the biochemical and amino acid profiles of liver tumor patients undergoing radiotherapy. MATERIALS AND METHODS: Patients were randomly assigned to one of 2 groups: a group given oral supplementation with BCAA granules (LIVACT granules; Samil Pharm Co., Korea, each granule containing L-isoleucine 952 mg, L-leucine 1,904 mg, and L-valine 1,144 mg) during radiotherapy, or a placebo group. Physical and biochemical examinations and measurements, including subjective symptoms, Child-Pugh class, body mass index, plasma albumin concentration, and plasma amino acid profiles were monitored. RESULTS: Fifty were enrolled between November 2005 and November 2006. We also analyzed data from 37 hepatocellular carcinoma (HCC) patients in order to evaluate a more homogenous group. The two groups of patients were comparable in terms of age, gender, Child-Pugh score, and underlying hepatitis virus type. Serum albumin, total protein, liver enzymes, and cholesterol showed a tendency to increase in the BCAA group. In this group, the percentage of cases that reverted to normal serum albumin levels between 3 and 10 weeks after administration of BCAA was significantly higher (41.18%) than in the placebo group (p=0.043). CONCLUSION: Oral supplementation with a BCAA preparation seems to help HCC patients undergoing radiotherapy by increasing the BCAA concentration.